Anastomosis device

ABSTRACT

An anastomosis device may include a central region, and at least one projection connected to the distal end of the central region, where at least one projection is foldable in at least the proximal direction. An anastomosis device may include a central region, and an inner flange connected to the distal end of the central region, the inner flange deployable from a first position to an expanded position, where the inner flange includes at least one substantially triangular inner flange element.

[0001] This application is a continuation of U.S. patent applicationSer. No. 09/664,588, filed on Sep. 18, 2000, which in turn is adivisional of U.S. Pat. No. 6,428,550, issued on Aug. 6, 2002, all ofwhich are incorporated by reference in their entirety.

BACKGROUND

[0002] 1. Field of the Invention

[0003] The invention relates to an anastomosis device for forming asutureless connection between two blood vessels.

[0004] 2. Brief Description of the Related Art

[0005] Vascular anastomosis is a procedure by which two blood vesselswithin a patient are surgically joined together. Vascular anastomosis isperformed during treatment of a variety of conditions including coronaryartery disease, diseases of the great and peripheral vessels, organtransplantation, and trauma. In coronary artery disease (CAD) anocclusion or stenosis in a coronary artery interferes with blood flow tothe heart muscle. Treatment of CAD involves the grafting of a vessel inthe form of a prosthesis or harvested artery or vein to reroute bloodflow around the occlusion and restore adequate blood flow to the heartmuscle. This treatment is known as coronary artery bypass grafting(CABG).

[0006] In the conventional CABG, a large incision is made in the chestand the sternum is sawed in half to allow access to the heart. Inaddition, a heart-lung machine is used to circulate the patient's bloodso that the heart can be stopped and the anastomosis can be performed.In order to minimize the trauma to the patient induced by conventionalCABG, less invasive techniques have been developed in which the surgeryis performed through small incisions in the patients chest with the aidof visualizing scopes. Less invasive CABG can be performed on a beatingor stopped heart and thus may avoid the need for cardiopulmonary bypass.

[0007] In both conventional and less invasive CABG procedures, thesurgeon has to suture one end of the graft vessel to the coronary arteryand the other end of the graft vessel to a blood supplying vein orartery, such as the aorta. The suturing process is a time consuming anddifficult procedure requiring a high level of surgical skill. In orderto perform the suturing of the graft to the coronary artery and theblood supplying artery the surgeon must have relatively unobstructedaccess to the anastomosis sites within the patient. In the less invasivesurgical approaches, some of the major anastomosis sites cannot beeasily reached by the surgeon because of their location. This makessuturing either difficult or impossible without opening up the chestcavity.

[0008] An additional problem with CABG is the formation of thrombi andatherosclerotic lesions at and around the grafted artery, which canresult in the reoccurrence of ischemia. Thrombi and atheroscleroticlesions may be caused by the configuration of the sutured anastomosissite. For example, an abrupt edge at the anastomosis site may cause morecalcification than a more gradual transition. However, the preferredgradual transition is difficult to achieve with conventional suturingmethods.

[0009] Accordingly, it would be desirable to provide a suturelessvascular anastomosis device which easily connects a graft to a targetvessel. It would also be desirable to provide a sutureless anastomosisdevice which is formed of one piece and is secured to the target vesselin a single step.

SUMMARY OF THE INVENTION

[0010] The present invention relates to an anastomosis device forconnecting an end of a graft vessel to a target vessel. The anastomosisincludes a first linkage formed of a plurality of struts and a pluralityof axial members. The first linkage is expandable from a firstconfiguration in which the first linkage is a substantially cylindricalshape to a second configuration in which the first linkage includes afirst radially extending flange. A substantially cylindrical centralconnecting portion extends from the first linkage. A second linkage isconfigured to form a second radially extending flange spaced from thefirst radially extending flange.

[0011] In accordance with an additional aspect of the present invention,an anastomosis device for connecting an end of a graft vessel to atarget vessel includes an expandable device formed from a plurality ofstruts and deformable from a first configuration in which the device issubstantially tubular to a second configuration in which the deviceincludes a first radial flange and a second radial flange spaced fromthe first radial flange a distance sufficient to accommodate a wall of ablood vessel. A first end of the expandable device includes a firstlinkage which changes from a substantially tubular configuration to aradially extending configuration to form the first flange upon radialexpansion of the first end by an expander positioned in a center of theexpandable device. A second end of the expandable device includes asecond linkage which is configured to form the second radial flange upondeployment of the device.

[0012] In accordance with another aspect of the present invention, amethod of performing anastomosis includes the steps of providing aone-piece tubular anastomosis device; everting an end of a graft vesselaround the anastomosis device; puncturing a target vessel with a trocar;inserting the tubular anastomosis device with everted graft vessel intothe puncture in the target vessel; radially expanding the tubularanastomosis device with an expander to cause portion of the tube to foldoutward forming a first annular flange; and forming a second annularflange on the anastomosis device to trap a wall of the target vesselbetween the first and second annular flanges and seal the graft vesselto the target vessel.

[0013] In accordance with a further aspect of the present invention, ananastomosis device deployment system includes a handle, a holder tubeattached to the handle, and an expander positioned within the holder andslidable with respect to the holder to a position at which the expanderis positioned within the anastomosis device to radially expand theanastomosis device. The holder tube has a distal end configured to holdthe anastomosis device with an attached graft vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The invention will now be described in greater detail withreference to the preferred embodiments illustrated in the accompanyingdrawings, in which like elements bear like reference numerals, andwherein:

[0015]FIG. 1 is a perspective view of a first embodiment of ananastomosis device in a configuration prior to use with a graft vesseleverted over the device;

[0016]FIG. 2 is a perspective view of the anastomosis device of FIG. 1in a deployed configuration;

[0017]FIG. 3 is a perspective view of a second embodiment of ananastomosis device in a configuration prior to use with a graft vesseleverted over the device;

[0018]FIG. 4 is a perspective view of the anastomosis device of FIG. 3in a deployed configuration;

[0019]FIG. 5 is a perspective view of a third embodiment of ananastomosis device in a configuration prior to use with a graft vesseleverted over the device;

[0020]FIG. 6 is a perspective view of the anastomosis device of FIG. 5in a deployed configuration;

[0021]FIG. 7 is a perspective view of a fourth embodiment of ananastomosis device in a configuration prior to use with a graft vesseleverted over the device;

[0022]FIG. 8 is a perspective view of the anastomosis device of FIG. 7in a deployed configuration;

[0023]FIG. 9 is a perspective view of a fifth embodiment of ananastomosis device in a configuration prior to use with a graft vesseleverted over the device;

[0024]FIG. 10 is a perspective view of the anastomosis device of FIG. 9with a bottom flange in a deployed configuration;

[0025]FIG. 11 is a perspective view of the anastomosis device of FIG. 9with a bottom flange and a top flange both in deployed configurations;

[0026]FIG. 12 is a side view of a portion of a sixth embodiment of ananastomosis device which has been laid flat for ease of illustration;

[0027]FIG. 13 is a side view of a portion of a seventh embodiment of ananastomosis device which has been laid flat for ease of illustration;

[0028]FIG. 14 is a perspective view of an anastomosis device deploymentsystem;

[0029]FIG. 14A is an enlarged perspective view of the distal end of theanastomosis device deployment system of FIG. 14 with an anastomosisdevice prior to deployment;

[0030]FIG. 15 is a side cross sectional view of the anastomosis devicedeployment system puncturing the target vessel to advance theanastomosis device into the target vessel wall;

[0031]FIG. 16 is a side cross sectional view of the anastomosis devicedeployment system advancing the anastomosis device into the targetvessel wall;

[0032]FIG. 17 is a side cross sectional view of the anastomosis devicedeployment system with an expanded first annular flange;

[0033]FIG. 18 is a side cross sectional view of the anastomosis devicedeployment system expanding a second annular flange;

[0034]FIG. 19 is a schematic side cross-sectional view of a deploymenttool taken along line A-A of FIG. 14, the deployment tool is shownduring a vessel puncturing step;

[0035]FIG. 20 is a schematic side cross-sectional view of the deploymenttool of FIG. 19 shown during an anastomosis device insertion step;

[0036]FIG. 21 is a schematic side cross-sectional view of the deploymenttool of FIG. 19 shown during an anastomosis device expansion step;

[0037]FIG. 22 is a schematic side cross-sectional view of the deploymenttool of FIG. 19 shown after the anastomosis device has been fullydeployed;

[0038]FIG. 23 is a perspective view of a eighth embodiment of ananastomosis device in a configuration prior to use;

[0039]FIG. 23A is a side view of a portion of the anastomosis device ofFIG. 23 prior to folding a tab of the device inward;

[0040]FIG. 24 is a perspective view of the anastomosis device of FIG. 23in a deployed configuration;

[0041]FIG. 25 is a side view of a portion of a ninth embodiment of ananastomosis device which has been laid flat for ease of illustration;

[0042]FIG. 26 is a side view of a portion of a tenth embodiment of ananastomosis device which has been laid flat for ease of illustration;

[0043]FIG. 27 is a side view of a portion of an eleventh embodiment ofan anastomosis device which has been laid flat for ease of illustration;

[0044]FIG. 28 is a side view of an eleventh embodiment of an anastomosisdevice which has been laid flat for ease of illustration; and

[0045]FIG. 29 is a top view of the anastomosis device of FIG. 28 with aflange deployed.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] The present invention relates to an anastomosis device and methodfor connecting a graft vessel to a target vessel without the use ofconventional sutures. The anastomosis device according to the presentinvention can be deployed with a deployment system which greatlyincreases the speed with which anastomosis can be performed over priorart suturing methods. In addition, the anastomosis device provides asmooth transition between the graft vessel and the target vessel. Thedevices according to the present invention are particularly designed foruse in connecting graft vessels to blood delivery or target vessels.Suturing a graft vessel to a target vessel is difficult withconventional techniques, particularly in minimally invasive procedureswhere space may be limited. However, with an anastomosis device anddeployment system of the present invention, anastomosis can be performedefficiently and effectively in tight spaces.

[0047]FIG. 1 illustrates an anastomosis device 10 according to a firstembodiment of the present invention. The anastomosis device 10 includesa plurality of axial members 12 and a plurality of struts 14interconnecting the axial members. The axial members 12 and struts 14form a first linkage 16 at a first end of the device and a secondlinkage 18 at a second end of the device. The first and second linkages16, 18 form first and second flanges 20, 22 when the anastomosis device10 is deployed as illustrated in FIG. 2. The deployed flanges 20, 22 maybe annular ring shaped or conical in shape. The first and secondlinkages 16, 18 are connected by a central connecting portion 24.

[0048] In use, a graft vessel 30 is inserted through a center of thetubular anastomosis device 10 and is everted over the first linkage 16at the first end of the device. The first end of the device may puncturepart way or all the way through the graft vessel wall to hold the graftvessel 30 on the device. An opening 34 is formed in the target vessel 32to receive the graft vessel 30 and anastomosis device 10. Once theanastomosis device 10 with everted graft vessel 30 are inserted throughthe opening 34 in the target vessel 32, the first and second flanges 20,22 are formed as shown in FIG. 2 to secure the graft vessel to thetarget vessel by trapping the wall of the target vessel between the twoflanges. The anastomosis device 10 forms a smooth transition between thetarget vessel 32 and the graft vessel 30 which helps to prevent thrombiformation.

[0049] The first and second flanges 20, 22 are formed by radialexpansion of the anastomosis device 10 as follows. The first and secondlinkages 16, 18 are each made up of a plurality of axial members 12 andstruts 14. The struts 14 are arranged in a plurality-of diamond shapeswith adjacent diamond shapes connected to each other to form acontinuous ring of diamond shapes around the device. One axial member 12extends through a center of each of the diamond shapes formed by thestruts 14. A reduced thickness section 26 or hinge in each of the axialmembers 12 provides a location for concentration of bending of the axialmembers. When an expansion member such as a tapered rod or an inflatableballoon is inserted into the tubular anastomosis device 10 and used toradially expand the device, each of the diamond shaped linkages ofstruts 14 are elongated in a circumferential direction causing a top andbottom of each of the diamond shapes to move closer together. As the topand bottom of the diamond shapes move closer together, the axial members12 bend along the reduced thickness sections 26 folding the ends of thedevice outward to form the first and second flanges 20, 22. Once thefirst and second flanges 20, 22 have been formed, the wall of the targetvessel 32 is trapped between the flanges and the everted graft vessel 30is secured to the target vessel.

[0050] In the anastomosis device 10 shown in FIGS. 1 and 2, the struts14 may be straight or curved members having constant or varyingthicknesses. In addition, the axial members 12 may have the reducedthickness sections 26 positioned at a center of each of the diamondshapes or off center inside the diamond shapes. The positioning and sizeof the reduced thickness sections 26 will determine the location of theflanges 20, 22 and an angle the flanges make with an axis of the devicewhen fully deployed. A final angle between the flanges 20, 22 andlongitudinal axis of the device 10 is about 40-100 degrees, preferablyabout 50-90 degrees.

[0051]FIG. 3 illustrates a second embodiment of a tubular anastomosisdevice 40 formed of a plurality of struts 42 interconnected in a diamondpattern. A first end of the device includes a plurality of interiordiamonds 44 positioned within the diamonds formed by the plurality ofstruts 42. When the device is deployed, as illustrated in FIG. 4, theinterior diamonds 44 fold outward to form a first annular flange 46. Asecond end of the device 40 includes a plurality of pull tabs 48 eachhaving a T-shaped end 50 to be received in a corresponding slot in adeployment device. The deployment device holds the anastomosis device 40during positioning and deployment of the first flange 46. Once the firstannular flange 46 has been formed, the pull tabs 48 are folded radiallyoutward and downward in the direction of the arrows B to form a secondannular flange (not shown). Although the pull tabs 48 have beenillustrated with T-shaped ends, the pull tabs may have otherconfigurations such as loops which engage hooks of a deployment device.

[0052] In use, the graft vessel 30 is inserted through a center of thetubular anastomosis device 40 and everted over the first end of thedevice as shown in FIG. 3. An opening 34 is formed in the target vessel32 and the anastomosis device 40 with the everted graft vessel 30 areinserted through the opening 34 in the target vessel. An expander isthen advanced axially through the anastomosis device 40 to radiallyexpand the device and cause the deployment of the first annular flange46. During advancement of the expander, the device 40 is held in placeby the deployment device which is connected to the T-shaped ends 50 ofthe pull tabs 48. After deployment of the first annular flange 46 theexpander is removed and the pull tabs 48 are disconnected from thedeployment device and folded outward in the direction of the arrows B inFIG. 4 to form the second annular flange. The wall of the target vessel32 is trapped between the first and second annular flanges.

[0053] In the embodiment of FIGS. 3 and 4, the interior diamonds 44which form the first annular flange 46 each include top and bottomreduced thickness connection members 54 which connect the interiordiamonds 44 to the struts 42. Each of the interior diamonds 44 alsoinclude a U-shaped web member 56 and two reduced thickness portions 58located at opposite sides of the interior diamonds. As the device 40 isradially expanded, the diamond shapes formed by the struts 42 becomemore elongated in a circumferential direction, shortening the height ofeach of these diamond shapes. As the height of the diamond shapes formedby the struts 42 decreases, the interior diamonds 44 are folded outwardinto the configuration illustrated in FIG. 4. When the device 40 isfully expanded and the first annular flange 46 is fully formed, thediamonds which originally surrounded the interior diamonds 44 arecompletely extended and the struts 42 which originally formed thediamonds are parallel or substantially parallel. The interior diamonds44 are each folded in half at the reduced thickness portions 58 orhinges.

[0054]FIGS. 5 and 6 illustrate a third embodiment of a tubularanastomosis device 60 having a plurality of struts 62, interior diamonds64, and a plurality of pull tabs 68. The anastomosis device 60 of FIGS.5 and 6 differs from the anastomosis device 40 of FIGS. 3 and 4 in thearrangement of the interior diamonds 64. The interior diamonds 64, asillustrated in FIG. 5, are connected to the surrounding struts 62 bythree connection members 70. The connection members 70 are located atopposite sides of each of the interior diamonds 64 and at the bottom ofthe interior diamonds. A top-corner 72 of each of the interior diamonds64 is not connected to the struts and folds inward upon expansion of thedevice.

[0055] With this embodiment of FIGS. 5 and 6, as an expander is insertedaxially through the anastomosis device 60, the top corners 72 of each ofthe interior diamonds 64 fold inwardly while a bottom edge of the devicefolds outwardly to form the first annular flange 66. The expander mayalso push on the inwardly folded top corners 72 of the interior diamonds64 to further bend the first flange 66 outward. The device 60 alsoincludes a plurality of pointed ends 74 which puncture the everted graftvessel 30 and help to retain the graft vessel on the anastomosis device60.

[0056] In use, the anastomosis device 60 is provided with a graft vessel30 which is inserted through a center of the device and everted over thepointed ends 74 and interior diamonds 64 of the device. The anastomosisdevice 60 and everted graft vessel 30 are then inserted in the opening34 in the target vessel 32 and the first annular flange 66 is deployedby expansion of the device with an axially movable expander. Afterformation of the first annular flange 66, the pull tabs 68 are foldeddownward and outward in the direction of the arrows B illustrated inFIG. 6 to form the second annular flange and trap the wall of the targetvessel between the first and second annular flanges.

[0057] An alternative embodiment of an anastomosis device 80 illustratedin FIGS. 7 and 8 includes two rows of diamond-shaped members 82 whichfold outward to form the first and second annular flanges 84, 86. Eachof the diamond-shaped members 82 is connected to M-shaped struts 88 atone end and to V-shaped struts 90 at an opposite end. The diamond-shapedmembers 82 are connected only at the top end and bottom end. A centralconnecting portion 92 of the device 80 includes a plurality of largediamond-shaped support members 94. As an expander is inserted into thedevice 80, the device expands from a configuration illustrated in FIG. 7to the configuration illustrated in FIG. 8 in which the first and secondannular flanges 84, 86 have been formed. During expansion, the M-shapedstruts 88 and the V-shaped struts 90 are extended to straight orsubstantially straight members and the large diamond support members 94move away from one another. The diamond-shaped members 82 each fold inhalf at reduced thickness portions 96 as in the embodiment illustratedin FIGS. 3 and 4.

[0058]FIGS. 9-11 illustrate a further alternative embodiment of ananastomosis device 100 according to the present invention. The device100 includes a plurality of axial members 102 having reduced thicknessportions 104. Each of the axial members 102 is positioned within amulti-sided expandable linkage 106. A central connecting portion 108connects the expandable linkage 106 to a plurality of pull tabs 110.Each of the pull tabs 110 has a T-shaped end 112 which is received in acorresponding slot in a deployment device to hold the anastomosis device100 during insertion and expansion. However, other pull tab shapes mayalso be used. As an expander is inserted axially into the anastomosisdevice 100, the linkage 106 expands causing the axial members 102 tofold along the reduced thickness portions 104 and extend radiallyoutward forming a first radial flange 114, as illustrated in FIG. 10.The first radial flange 114 may be configured to extend at an acuteangle from an axis of anastomosis device 100 or may be folded to form anangle of up to 90 degrees or greater. The angle between the axis ofanastomosis device and the lower portion of the axial members 102 afterthe first radial flange 114 has been deployed is preferably betweenabout 40 and 100 degrees. After the first radial flange has beendeployed, the pull tabs 110 are disengaged from the deployment deviceand folded outwards in the direction of the arrows B to form a secondradial flange 116 as illustrated in FIG. 11. To disengage and fold thepull tabs 110 outwards, the deployment device is moved distally withrespect to the anastomosis device. The first and second radial flanges114, 116 trap a wall of the target vessel 32 between the flanges andthus secure the everted graft vessel 30 to the target vessel.

[0059]FIGS. 12 and 13 illustrate alternative embodiments of the device100 of FIGS. 9 through 11. The expandable tubular anastomosis device 120of FIG. 12 has been cut and laid flat for ease of illustration. Thedevice 120 includes a plurality of axial members 122 having hinges 124in the form of U-shaped grooves. The axial members 122 are each mountedat opposite ends in an expandable linkage 126. The expandable linkage126 is at one end of the device 120 while an opposite end of the deviceincludes a plurality pull tabs 130. The pull tabs 130 and linkage 126are connected by a central connecting portion 128. Each of the pull tabs130 has a T-shaped end 132, a shoulder 134, and a triangular slot 136.Extending from an end of each of the pull tabs 130 opposite the T-shapedends 132 is a tab lock 138.

[0060] In use, the anastomosis device 120 of FIG. 12 is used in a mannersubstantially similar to that of the device shown in FIGS. 9-11. Inparticular, the device 120 is attached to an deployment tool by theT-shaped ends 132 of the pull tabs 130. A graft vessel is extendedthrough the center of the tubular device 120 and everted around the endof the device opposite the pull tabs 130. An expander is advancedaxially into the device to expand the expandable linkage 126 and causethe lower portion of each of the axial members 122 below the hinges 124to bend outward to form a first flange. The material in the center ofeach of the U-shaped cuts which form the hinges 124 serves as a backstopto prevent the flange from bending or rolling due to radial compressiveforces applied to the flange by the stretched graft vessel. In contrast,with the narrowed section hinge shown in FIG. 1 the bend at the hingetends to roll away from the desired hinge point due to compressiveforces applied by the graft vessel. The backstop hinge 124 preventsrolling of the bend along the axial member 122.

[0061] After formation of the first flange with the expander, theexpander is withdrawn. During this withdrawal of the expander, anannular groove on an exterior surface of the expander engages the tablocks 138 causing the pull tabs 130 to bend outwardly to form the secondflange. Alternatively, the tab locks 138 may be caught on a leading edgeof the expander. As the pull tabs 130 bend outwardly, the T-shaped ends132 of the pull tabs disengage from the deployment device. According toone embodiment of the invention, the second flange is formed by a firstbend in the pull tabs 130 at a location between the triangular slot 136and the lock tab 138 and a second bend in the pull tab at the shoulder134. These two bends in the pull tabs 130 allow the anastomosis deviceto accommodate target vessels with different wall thicknesses. Each ofthe two bends preferably forms an angle of about 20-70 degrees.

[0062]FIG. 13 illustrates a further embodiment of a tubular anastomosisdevice 120′ which corresponds substantially to the device shown in FIG.12. However, FIG. 13 illustrates several different variations of hinges124′ for the axial members 122′. In particular, the hinges 124′ may beformed in any of the different manners illustrated in FIG. 13 byremoving material from the axial members 122′ to cause bending at thedesired location. These hinges 124′ may include openings of variousshapes and/or cut away portions on the sides of the axial members 122′.The different hinge configurations have been shown in one device onlyfor purposes of illustration.

[0063]FIGS. 14-18 illustrate a deployment system 150 and sequence ofdeploying an anastomosis device 120 such as the device shown in FIG. 12with the deployment system. In FIGS. 14-16 the graft vessel 30 has beeneliminated for purposes of clarity. As shown in FIGS. 14-18, thedeployment system 150 includes a hollow outer trocar 152 (not shown inFIG. 14), a holder tube 154 positioned inside the trocar, and anexpander tube 156 slidable inside the holder tube. As can be seen in thedetail of FIG. 14A, the anastomosis device 120 is attached to a distalend of the holder tube 154 by inserting the T-shaped ends 112 of each ofthe pull tabs 110 in slots 158 around the circumference of the holdertube. The trocar 152, holder tube 154, and expander tube 156 are allsidable with respect to one another during operation of the device. Adevice handle 160 is provided for moving the tubes with respect to oneanother will be described in further detail below with respect to FIGS.19-22.

[0064] As shown in FIG. 15, initially, the holder tube 154, expandertube 156, and the anastomosis device 120 are positioned within thetrocar 152 for insertion. The trocar 152 has a hollow generally conicaltip with a plurality of axial slots 162 which allow the conical tip tobe spread apart so that the anastomosis device 120 can slide through theopened trocar. The trocar 152, acting as a tissue retractor and guide,is inserted through the wall of the target vessel 32 forming an opening34. As shown in FIG. 16, the anastomosis device 120 is then advancedinto or through the target vessel wall 32 with the holder tube 154. Theadvancing of the holder tube 154 causes the distal end of the trocar 152to be forced to spread apart. Once the anastomosis device 120 is inposition and the trocar 152 has been withdrawn, the first annular flangeis deployed by advancing the expander tube 156 into the anastomosisdevice. The advancing of the expander tube 156 increases the diameter ofthe anastomosis device 120 causing the first flange to fold outward fromthe device. This expanding of the first flange may be performed insidethe vessel and then the device 120 may be drawn back until the flangeabuts an interior of the target vessel wall 32.

[0065] As shown in FIG. 18, after the first flange has been deployed,the expander tube 156 is withdrawn forming the second flange. As theexpander tube 156 is withdrawn, the anastomosis device 120 drops into aradial groove 157 on an exterior of the expander tube due to theelasticity of the device. The radial groove 157 holds the anastomosisdevice 120 stationary on the expander tube. The holder tube 154 is thenmoved forward disengaging the anastomosis device pull tabs 130 from theslots 158 in the holder tube. The shoulders 134, shown most clearly inFIGS. 15 and 16, engage a tapered distal end of the holder tube 154causing the pull tabs 130 to be released from the slots 158. As theholder tube 154 is moved further forward, the holder tube causes thesecond flange to be deployed. The edges of the radial groove 157 arepreferably beveled so that the anastomosis device 120 will be able to beremoved from the expander tube 156 after the anastomosis device iscompletely deployed.

[0066] One alternative embodiment of the holder tube 154 employs aplurality of flexible fingers which receive the pull tabs 130 of theanastomosis device 120. According to this embodiment each pull tab 130is received by an independent finger of the holder tube 154. To deploythe second or outer flange of the anastomosis device 120, the flexiblefingers flex outward bending the pull tabs 130 outward.

[0067]FIGS. 19-22 illustrate the operation of the handle 160 to move thetrocar 152, the holder tube 154, and the expander tube 156 with respectto one another to deploy the anastomosis device 120 according to thepresent invention. The handle 160 includes a grip 170 and a trigger 172pivotally mounted to the grip at a pivot 174. The trigger 172 includes afinger loop 176 and three contoured cam slots 178, 180, 182corresponding to the trocar 152, holder tube 154, and expander tube 156,respectively. Each of these tubes has a fitting 184 at a distal endthereof. A pin 186 connected to each of the fittings 184 slides in acorresponding one of the cam slots 178, 180, 182. A fourth cam slot andtube may be added to control deployment of the second flange.

[0068] The handle 160 is shown in FIG. 18 in an insertion position inwhich the trocar 152 extends beyond the holder tube 154 and the expandertube 156 for puncturing of the target vessel wall 32. As the trigger 172is rotated from the position illustrated in FIG. 19 to the successivepositions illustrated in FIGS. 20-22, the pins 186 slide in the camslots 178, 180, 182 to move the trocar 152, holder tube 154 and expandertube 156.

[0069]FIG. 20 shows the handle 160 with the trigger 172 rotatedapproximately 30 degrees from the position of FIG. 19. This rotationmoves the holder tube 154 and expander tube 156 forward into the wall ofthe target vessel 32 spreading the trocar 152. The anastomosis device120 is now in position for deployment. FIG. 21 shows the trigger 172rotated approximately 45 degrees with respect to the position of FIG. 19and the cam slot 182 has caused the expander tube 156 to be advancedwithin the holder tube 154 to deploy the first flange. The trocar 152has also been withdrawn.

[0070]FIG. 22 shows the handle 160 with the trigger 172 pivotedapproximately 60 degrees with respect to the position shown in FIG. 19.As shown in FIG. 22, the expander tube 156 has been withdrawn to pullthe first flange against the vessel wall 32 and the holder tube 154 ismoved forward to deploy the second flange and disengage the holder tube154 from the anastomosis device 120.

[0071] The handle 160 also includes a first channel 188 and a secondchannel 190 in the grip 170 through which the graft vessel (not shown)may be guided. The grip 170 also includes a cavity 192 for protecting anopposite end of the graft vessel from the attachment end.

[0072]FIG. 23-26 illustrate a further alternative embodiment of theanastomosis device according to the present invention. As shown in FIG.23, an anastomosis device 200 includes a plurality of pull tabs 202, adiamond linkage 204, and a plurality of needles 206. As shown in thedetail of FIG. 23A, each of the needles 206 has a tail portion 208 whichis bent radially inwardly as shown in FIG. 23 prior to use. In thisembodiment, the graft vessel is inserted through the center of theanastomosis device 200 and everted over the needles 206 as in theprevious embodiments. The needles 206 puncture the graft vessel andsecurely retain the graft vessel on the anastomosis device. To deploythe device 200 of FIG. 23, an expander 210 is inserted axially into thedevice in a direction of the arrow C and engages the tail portions 208of the needles 206 to fold the needles radially outward. The expander210 is preferably larger in diameter than an original inner diameter ofthe device 200 such that the device is expanded during deployment. Thisexpansion will stretch the opening in the target vessel 32 providing abetter seal between the graft and target vessels. However, it should beunderstood that an outer diameter of the expander 210 according to thisembodiment can be equal to or smaller than an inner diameter of thedevice 200 and can bend the needles 206 outward without radiallyexpanding the device.

[0073]FIG. 24 illustrates the device 200 of FIG. 23 in which theexpander has been used to radially expand the device and bend theneedles 206 outward. The pull tabs 202 are then folded downward to trapthe wall of the target vessel 32 between the needles 206 and the pulltabs.

[0074]FIGS. 25 and 26 illustrate two modified versions of the embodimentof FIG. 23. The variations of FIGS. 24 and 25 each include pull tabs202, diamond linkages 204, and needles 206 having tail portions 208 bentinwardly. FIG. 25 and 26 also illustrate horns 212 which help to retainthe graft vessel after eversion.

[0075] A cantilevered end of each of the axial members may be eitherrounded as shown in FIGS. 12 and 13 or pointed as shown in FIGS. 1, 2, 5and 6. The rounded cantilever ends prevent puncturing of the graftvessel while the pointed cantilever ends puncture through the vessel andprevent the vessel from slipping off of the anastomosis device. Thepuncturing of the vessel also relieves stresses on the vessel which arecreated when expanding the first flange. Although the pointed cantileverends may provide more secure retention of the graft vessel, thesepointed ends will provide undesirable metal within the bloodstream.

[0076]FIG. 27 illustrates a modified version of the anastomosis deviceof FIG. 12 in which the anastomosis device 120″ includes modifiedneedles 206′ with saw tooth edges for grasping tissue of the graftvessel. This version of the anastomosis device 120″ also includesbackstop hinges 124 and pull tabs 130.

[0077]FIGS. 28 and 29 illustrate an alternative embodiment of ananastomosis device 220. Having the first flange formed from a pluralityof members 222 which fold out tangentially from a body of theanastomosis device. The device 220 includes pull tabs 224, connected bya diamond linkage 226 to the members 222. As the diamond linkage 226 isexpanded in the manner described above with respect to the earlierembodiments, the members 222 fold outward in a direction which issubstantially tangential to a body of the expanding device as shown inFIG. 28. The tangentially folded members 222 form the inner flange ofthe device 220. The pull tabs 224 are then folded downward to form theouter flange. According to this embodiment of the invention, a secondflange may also be formed from a plurality of members which fold outtangentially from a body of the anastomosis device.

[0078] Each of the anastomosis devices described above are preferablysingle piece devices which are formed by laser cutting or punching froma tube or sheet of material. The devices may be provided in varyingsizes to join vessels of different sizes. The linkages, pull tabs, andother elements which have been discussed above with regard to thevarious embodiments may be used in varying numbers and arrangements.

[0079] The invention has been described as an anastomosis device whichis expanded with an expander. The expander may be a tube, a balloon, orany other known expanding device.

[0080] Although the invention has been principally discussed withrespect to coronary bypass surgery, the anastomosis devices of thepresent invention may be used in other types of anastomosis procedures.For example, the anastomosis device may be used in femoral-femoralbypass, vascular shunts, subclavian-carotid bypass, organ transplants,and the like.

[0081] The anastomosis devices may be made of any known material whichcan be bent and will retain the bent shape such as stainless steel,nickel titanium alloys, and the like. The hinges or pivot joints whichhave been discussed above in the various embodiments of the presentinvention are designed to concentrate the bending at a desired location.For example, the hinges may be formed with a reduced thickness or width,or with openings in order to concentrate the bending in the hinges.

[0082] The dimensions of the anastomosis device of the present inventionare determined by the dimensions of the blood vessels to be joined. Adistance between the two flanges is designed to accommodate the wallthickness of a target vessel which may vary. The anastomosis devicesaccording to the present invention have been illustrated as cylindricalmembers. However, the devices may also be shaped into oval shapes,football shapes, or other shapes to accommodate smaller target vessels.

[0083] While the invention has been described in detail with referenceto the preferred embodiments thereof, it will be apparent to one skilledin the art that various changes and modifications can be made andequivalents employed, without departing from the present invention.

What is claimed is:
 1. An anastomosis device, comprising: a central region, comprising a plurality of struts; and at least one projection connected to the distal end of said central region, wherein at least one said projection is foldable in at least the proximal direction.
 2. The anastomosis device of claim 1, wherein at least one said projection includes at least one member extending at least partially along a perimeter of an open area.
 3. The anastomosis device of claim 1, wherein at least one said projection is substantially trapezoidal.
 4. The anastomosis device of claim 1, wherein at least one said projection is substantially diamond-shaped.
 5. The anastomosis device of claim 1, wherein at least one said projection is substantially triangular.
 6. The anastomosis device of claim 1, wherein said central region is radially expandable along at least part of its length.
 7. The anastomosis device of claim 1, wherein at least one said projection is made of superelastic material.
 8. The anastomosis device of claim 8, wherein said superelastic material is nickel-titanium alloy.
 9. The anastomosis device of claim 1, wherein said struts extend substantially longitudinally.
 10. The anastomosis device of claim 1, wherein said struts are spaced apart from one another.
 11. An anastomosis device, comprising: a central region; and an inner flange connected to the distal end of said central region and deployable from a first position to an expanded position, wherein said inner flange includes at least one generally triangular inner flange element.
 12. The anastomosis device of claim 11, wherein at least one said triangular inner flange element further comprises an axial member connected to and substantially bisecting said triangular inner flange element.
 13. The anastomosis device of claim 11, wherein at least one said triangular inner flange element is substantially open.
 14. The anastomosis device of claim 11, further comprising an outer flange connected to the proximal end of said central region and deployable to an expanded position, wherein said outer flange includes at least one outer flange element radially offset from said at least one generally triangular inner flange element.
 15. The anastomosis device of claim 14, wherein at least one said outer flange element is generally triangular.
 16. The anastomosis device of claim 11, wherein at least one said triangular outer flange element is substantially open.
 17. The anastomosis device of claim 11, wherein said central region is radially expandable along at least part of its length.
 18. The anastomosis device of claim 11, wherein said inner flange is made of superelastic material.
 19. The anastomosis device of claim 18, wherein said superelastic material is nickel-titanium alloy.
 20. An anastomosis device, comprising: an inner flange and deployable from a first position to an expanded position, wherein said inner flange includes at least one generally triangular inner flange element; and an outer flange proximal to said inner flange and deployable to an expanded position, wherein said outer flange includes at least one outer flange element.
 21. The anastomosis device of claim 20, wherein at least one said outer flange element is radially offset from said at least one generally triangular inner flange element.
 22. The anastomosis device of claim 20, wherein at least one said outer flange element is generally triangular. 